Surgical seal assembly

ABSTRACT

A surgical seal assembly, includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/823,560, filed Jun. 28, 2007, which claims the benefit of andpriority to U.S. Provisional Patent Application No. 60/819,434, filedJul. 7, 2006, the entire disclosures of which are incorporated byreference herein.

BACKGROUND

1. Technical Field

The present disclosure relates to a surgical device and, moreparticularly, relates to a surgical seal assembly for a cannula assemblyand having a compliant guide for directing a surgical instrument along apath generally coincident with a seal axis.

2. Description of the Prior Art

Minimally invasive surgical procedures including both endoscopic andlaparoscopic procedures permit surgery to be performed on organs,tissues and vessels far removed from an opening within the tissue.Laparoscopic and endoscopic procedures generally require that anyinstrumentation inserted into the body be sealed, i.e. provisions mustbe made to ensure that gases do not enter or exit the body through theincision as, for example, in surgical procedures in which the surgicalregion is insufflated. These procedures typically employ surgicalinstruments which are introduced into the body through a cannula. Thecannula has a housing at a proximal end thereof in which a seal assemblyis mounted. The seal assembly provides a substantially fluid tight sealabout the instrument to preserve the integrity of the establishedpneumoperitoneum.

Minimally invasive procedures have several advantages over traditionalopen surgery, including less patient trauma, reduced recovery time,reduced potential for infection, etc. . . . However, despite its recentsuccess and overall acceptance as a preferred surgical technique,minimally invasive surgery, such as laparoscopy, has severaldisadvantages. In particular, the insertion of the surgical instrumentwithin the cannula has proven to be difficult in certain procedures,e.g., in procedures requiring extensive manipulation of the long narrowendoscopic instruments within a remote site. In addition, manyconventional seal assemblies are not particularly well-adapted toreceive a surgical instrument if it is inserted at an angle. This typeof insertion often results in the instrument missing the target (e.g.septum seal, etc.) and becoming lodged in an undesirable location withinthe seal assembly. There remains a need for an apparatus that may beused to guide a surgical instrument through a seal assembly in a moreefficient and efficacious manner.

SUMMARY

Accordingly, a surgical seal assembly for use with a cannula assembly isdisclosed. The surgical seal assembly includes a seal housing defining alongitudinal housing axis and having a longitudinal openingtherethrough, a seal having an inner seal portion defining a passage andbeing adapted to form a substantial seal about a surgical instrumentdisposed within the passage and a guide mounted to the proximal end ofthe seal housing. The guide has an inner guide portion proximal of theinner seal portion of the seal and spaced therefrom. The inner guideportion defines a channel adapted to generally direct the surgicalinstrument toward the inner seal portion of the seal upon entry of thesurgical instrument within the longitudinal opening of the seal housing.The inner guide portion is relatively compliant to accommodate initialoffset or angled entry of the surgical instrument. The inner guideportion of the guide may include an elastomeric material.

The channel of the guide is generally tapered in configuration, having aproximal entry opening and a distal exit opening. The distal exitopening defines an internal dimension less than a corresponding internaldimension of the proximal exit opening. The channel may define a generalfrusto-conical configuration. The inner guide portion of the guide isadapted to permit passage of the surgical instrument through the channelwithout forming a seal about the surgical instrument. The guide mayinclude a plurality of compliant members. The compliant memberspreferably extend at least radially inwardly relative to thelongitudinal axis. Preferably, the compliant members extend in a generaldirection having radial and longitudinal components of directionrelative to the longitudinal axis. The compliant members may be mountedin cantilevered relation to the seal housing and may pivot slightly uponengagement with the surgical instrument. The compliant members may bearranged such that adjacent compliant members are in partial overlappingrelation.

The seal housing includes an internal wall defining an internaldimension less than the internal dimension of the proximal entry openingof the channel of the guide to generally restrict the internal dimensionof the longitudinal opening of the seal housing.

In another embodiment, a surgical assembly includes a cannula assemblyand a seal assembly. The cannula assembly includes a cannula housing anda cannula sleeve extending from the cannula housing. The cannulaprovides access to an underlying surgical site. The seal assemblyincludes a seal housing adapted for releasable connection to the cannulahousing and having a longitudinal opening therethrough, a seal havinginner seal portions adapted to form a substantial seal about a surgicalinstrument and a guide connected to an exterior surface of the sealhousing. The guide includes a relatively compliant inner guide portionadapted to accommodate initial offset entry of the surgical instrumentwithin the seal housing and being mounted with respect to the sealhousing to direct the surgical instrument toward the inner seal portionof the seal during continued advancement of the instrument through thelongitudinal opening of the seal housing. The cannula assembly mayinclude a valve adapted to close in the absence of the surgicalinstrument inserted therethrough and open in the presence of thesurgical instrument. The inner guide portion of the guide is isolatedfrom the inner seal portion of the seal to not interfere with thefunctioning of the seal. The guide may include a plurality of compliantmembers coaxially arranged about the longitudinal axis. The inner guideportion of the guide is adapted to permit passage of the surgicalinstrument through the channel without forming a seal about the surgicalinstrument. The guide may be disposed proximal of the seal.

A method for performing a surgical procedure is also disclosed. Themethod includes the steps of:

accessing an underlying operative site with a cannula assembly;

mounting a seal assembly to the cannula assembly, the seal assemblyincluding a seal housing, a seal mounted within the seal housing and aguide mounted to the seal housing proximal of the seal;

introducing a surgical instrument within the seal assembly whereby theguide generally directs the surgical instrument toward an internalpassage of the seal without forming a seal thereabout, the guide beingspaced from the internal passage so as to not interfere with thefunctioning of the seal; and

performing a surgical procedure with the surgical instrument

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present disclosure are describedhereinbelow with references to the drawings, wherein:

FIG. 1 is a perspective view with parts separated of the seal assemblyof the present disclosure in accordance with the principles of thepresent disclosure illustrated with a cannula assembly and a trocarassembly;

FIG. 2 is a side cross-sectional view of the surgical seal assembly ofFIG. 1;

FIG. 3 is a perspective view of the compliant guide of the surgical sealassembly of FIGS. 1-2;

FIG. 4 is a side cross-sectional view of an alternate embodiment of thesurgical seal assembly of the present disclosure; and

FIG. 5 is a perspective view of a compliant guide having a plurality ofcompliant members in accordance with another alternate embodiment of thesurgical seal assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

The surgical seal assembly of the present disclosure provides asubstantial seal between a body cavity of a patient and the outsideatmosphere during insertion of a surgical instrument through theassembly. Moreover, the seal assembly guides the instrument through theassembly and places it in a desirable position for passage through theseal. This guide greatly facilitates endoscopic surgery where surgicalinstruments may be introduced off-axis or angulated with respect to theseal axis and as a result could become lodged within the seal assembly.The surgical seal assembly may be adapted for mounting to a conventionalcannula assembly as will be described hereinbelow.

The presently disclosed seal assembly contemplates the introduction ofvarious types of surgical instruments adapted for insertion through anelongated trocar assembly. Some possible examples of such instrumentsmay include clip appliers, graspers, dissectors, retractors, staplers,laser fibers, photographic devices, endoscopes and laparoscopes, tubesetc. Such instruments are collectively referred to herein asinstruments.

In the following description, the term “proximal” refers to the portionof the instrument closest to the operator, while the term “distal”refers to the portion of the instrument remote from the operator.

Referring to FIG. 1, the seal assembly 100 of the present disclosure isshown with a cannula assembly 200. Cannula assembly 200 may be anyconventional cannula assembly suitable for the intended purpose ofaccessing a body cavity and permitting introduction of instrumentstherethrough. Cannula assembly 200 is particularly adapted for use inlaparoscopic surgery where the peritoneal cavity is insufflated with asuitable gas, e.g., CO₂, to raise the cavity wall from the internalorgans therein. The cannula assembly 200 is typically used with anobturator assembly 300 which is an elongate instrument positionablewithin the cannula assembly. The obturator assembly 300 may have a sharpend or a blunt end and is utilized to pass through, e.g., abdominaltissue, to facilitate introduction of the cannula assembly within theabdominal cavity. Once access to the abdominal cavity is achieved, theobturator assembly 300 is removed from the cannula assembly 200 leavingthe cannula assembly 200 in place for introduction of the surgicalinstrumentation utilized to perform the procedure. Examples of cannulaassemblies in which the present seal assembly 100 may be utilized aredisclosed in commonly assigned U.S. Pat. No. 5,603,702 to Smith et al.,which issued on Feb. 18, 1997, and commonly assigned U.S. Pat. No.5,807,338 to Smith et al., which issued on Sep. 15, 1998, the entirecontents of each disclosure being hereby incorporated by referenceherein.

Cannula assembly 200 includes cannula sleeve 202 and cannula housing 204mounted to an end of the sleeve 202. Cannula sleeve 202 defines alongitudinal axis “a” extending along the length of sleeve 202. Sleeve202 further defines an internal longitudinal passage 206 dimensioned topermit passage of surgical instrumentation.

Cannula housing 204 may be a multi-component element secured via a snapfit, ultrasonic welding or any other means envisioned by one skilled inthe art including, e.g., adhesive means. Cannula housing 204 may furtherinclude diametrically opposed housing grips 208 dimensioned and arrangedfor gripping engagement by the fingers of the user. Cannula housing 204may further include an internal duck bill or zero closure valve 210.Such zero closure valve 210 opens to permit passage of the surgicalinstrumentation and closes in the absence of the instrumentation. Thevalve may be preferably adapted to close upon exposure to the forcesexerted by the insufflation gases in the internal cavity. Other zeroclosure valves are also contemplated including single or multiple slitvalve arrangements, trumpet valves, flapper valves, etc.

Cannula sleeve 202 and cannula housing 204 may be formed of stainlesssteel or other rigid materials such as a polymeric material or the like.Cannula sleeve 202 and/or cannula housing 204 may be clear or opaque.The diameter of sleeve 202 may vary, but typically ranges from 10 to 15mm for use with the seal assembly 100 of the present disclosure.

Obturator assembly 300 includes obturator housing 302 and obturatormember 304 extending from the housing 302. Obturator member 304 includesa penetrating end 306 adjacent its distal end. Penetrating end 306 maybe sharp or blunt. An obturator sleeve 308 is coaxially mounted aboutobturator member 304. Obturator sleeve 308 may retract to exposepiercing end 306. Alternatively, obturator member 304 may be advancedwithin obturator sleeve 308 to expose piercing end 306. Other alternateobturator mechanisms for exposing penetrating end 306 are alsoenvisioned.

Referring now to FIG. 2, in conjunction with FIG. 1, seal assembly 100will be discussed in detail. Seal assembly 100 includes seal housing,generally identified as reference numeral 102, and longitudinal opening104 extending through seal housing 102. Seal housing 102 houses thesealing components of the assembly and defines central seal housing axis“b” which is preferably parallel to the axis “a” of cannula sleeve 202and, more preferably, coincident with the axis “a” of the cannula whenthe seal assembly 100 is mounted to the cannula assembly 100. In oneembodiment, seal housing 102 may incorporate several housing components106, 108 which, when assembled together, form the seal housing 102.Assembly of housing components 106, 108 may be effected by any suitableadhesive means including adhesives, cements or the like or mechanicalmeans including tongue groove arrangements, bayonet couplings,interference fits, etc. Alternatively, seal housing 102 may bemonolithically formed as a single unit.

Seal housing 102 defines proximal and distal ends 110, 112,respectively. Adjacent proximal end 110 is internal tapered wall 114which extends radially inwardly toward seal housing axis ‘b” fromproximal to distal, i.e., tapered wall 114 has both longitudinal andradial components of direction, and terminates in internal annular wall116. Annular wall 116 serves to restrict the internal dimension oflongitudinal opening 104 to at least partially constrain lateralmovement of a surgical instrument introduced through seal housing 102.

Seal housing 102 may be constructed of a plurality of differentmaterials, including, but not limited to, polymeric, metallic, orelastomeric. Preferably, the components of seal housing 102 are formedof a polycarbonate material such as ABS available from the GeneralElectric Company. Seal housing 102 may further include a handle whichmay be of any suitable ergonomic design. Moreover, seal housing 102 maybe used in conjunction with, or detachably mounted, to cannula assembly200 such as those described hereinabove.

Seal assembly 100 includes seal 118 mounted within seal housing 102 insuspended relation. Seal 118 may be mounted within seal housing 102through conventional means such as for example with the use ofadhesives, cements or the like. Alternatively, or in conjunction withthe aforementioned adhesive means, seal 118 may be disposed or trappedbetween housing components 106,108 of seal housing 102 to effect themounting. It is also envisioned that seal 118 may be mounted in a mannerwhich permits radial or lateral movement of the seal 118 within sealhousing 102.

Seal 118 preferably includes inner seal portion 120 defining a passageadapted to form a substantial seal about a surgical instrument. Seal 118may be a septum seal incorporating a circular aperture 122 formed of anysuitable elastomeric material. In one embodiment, seal 118 is the fabricseal disclosed in commonly assigned U.S. Pat. No. 6,702,787 to Racenetet al., the entire contents of which are incorporated herein byreference. The seal disclosed in the '787 patent may be a flat septumseal having a first layer of resilient material and a second fabriclayer juxtaposed relative to the first layer. The fabric layer mayinclude a SPANDEX material containing 20% LYCRA from Milliken. In yetanother alternative, seal 118 is preferably a fabric seal and isdesirably arranged so as to have a constriction. The fabric is desirablyconstructed of a material that forms a constriction or closure. The sealmay also be molded with a resilient material so as to have aconstriction. Other arrangements for seal 110 are also envisioned.

Although seal 118 is disclosed as an impregnated fabric arrangement, itis appreciated that other seal types may be used and still achieve theobjectives of the present disclosure. For example, seal 118 may befabricated from an elastomeric material without the embedded fabric.Gel, foams, or other fluid-filled bladder seal arrangements are alsoenvisioned.

Referring now to FIGS. 2-3, seal assembly 100 further includes generallycompliant guide 124 which is mounted to an exterior surface of sealhousing 102 preferably adjacent internal tapered wall 114. Compliantguide 124 may be secured to the exterior surface, e.g., internal taperedwall 114 of seal housing 102 or mounted in suspended relation to theinternal tapered wall 114. Compliant guide 124 is generally tapered inconfiguration, e.g., generally frusto-conical shaped, having proximalentry opening 126 and distal exit opening 128, and inner guide portion130 defining internal channel 132. Preferably, distal exit opening 128defines an internal dimension greater than a corresponding internaldimension of aperture 122 of seal 118. In a preferred embodiment, innerguide portion 130 is dimensioned to permit passage of the surgicalinstrument through internal channel 132 without forming a seal about thesurgical instrument.

In use, compliant guide 124 is adapted to generally direct theinstrument toward the inner seal portion 120 of seal 118 uponadvancement of the instrument through longitudinal opening 104 of sealhousing 102. In one preferred embodiment, compliant guide 124 has acompliant characteristic which permits the compliant guide 124 todeflect upon engagement by a surgical instrument, such as, e.g., when aninstrument is initially introduced off axis or angulated with respect tothe seal housing axis “b”, to substantially prevent lodging of theinstrument within the compliant guide 124. Thereafter, the taperedorientation of compliant guide 124 guides the instrument along the sealaxis “b”. Compliant guide 124 may be constructed of a number ofdifferent compliant or flexible materials. In a preferred embodiment,compliant guide 124 is formed of an elastomeric material. Compliantguide 124 is preferably longitudinally spaced from seal 118 so as to notinterfere with the functioning of the seal 118.

It is envisioned that seal assembly 100 may be detachably connected tocannula assembly 200. Preferably, seal housing 102 is dimensioned to bereleasably mounted to cannula housing 204. In this regard, it isappreciated that seal housing 102 and cannula housing 204 mayincorporate means for facilitating the releasable connection of sealassembly 100 to cannula assembly 200 including, e.g., an interferencefit, bayonet coupling, screw arrangement, etc. . . . on correspondingstructure of the seal housing 102 and cannula housing 204. For example,seal housing 102 may include locking detents 136 (FIG. 1) which engagecorresponding structure on cannula housing 204 to secure seal assembly100 to cannula assembly 100. One suitable means for connecting the sealand cannula assemblies 100, 200 is disclosed in the aforementioned U.S.Pat. No. 5,603,702 to Smith et al. Thus, the surgeon can remove sealassembly 100 from the cannula assembly 200 at any time during thesurgical procedure and similarly, mount the seal assembly 100 to thecannula when desired in order to provide a sealing engagement with aninstrument to be inserted through the cannula. In addition, sealassembly 100 may be readily adapted for mounting to conventional cannulaof differing structures. Alternatively, seal housing 102 may bepermanently secured to cannula housing 204 if desired.

Referring now to FIG. 4, another embodiment of the seal assembly of thepresent disclosure will be discussed. Seal assembly 140 is substantiallysimilar to seal assembly 100 discussed hereinabove. However, inaccordance with this embodiment, seal assembly 140 includes compliantguide 142. Compliant guide 142 is mounted in cantilever manner to sealhousing 106 to provide a greater degree of flexing capability to thecompliant guide 142. In this regard, compliant guide 142 is spaced frominternal tapered wall 114. In addition, the effective internal dimensionadjacent the distal end of compliant guide 142 is less than the internaldimension or diameter of annular wall 116, i.e., compliant guide 142 isspaced a distance “d” from annular wall 116 such that the compliantguide 142 does not necessarily restrict the diameter of the opening ofhousing component 106. Any means for mounting compliant guide 142 in apivotal manner may be appreciated by one skilled in the art. In onepreferred embodiment, compliant guide 142 includes flange 144 which isaffixed through conventional means to proximal exterior surface 110 ofhousing component 106. In other respects, seal assembly 140 operates ina similar manner to that described hereinabove.

FIG. 5 illustrates an alternate embodiment of a compliant guide forincorporation with the seal assembly of the present disclosure.Compliant guide 150 includes a plurality of compliant members 152coaxially arranged about seal axis “s” to define opening 154. Compliantguide 150 may be mounted to seal housing 106 in pivotal relationsubstantially in the same manner as discussed in connection with theembodiment of FIG. 4 so as to provide a greater degree of flexibilityupon engagement and initial entry of the surgical instrument. In thisregard, compliant guide 150 includes flange 156 which is secured toproximal surface 110 of housing component 106 (see FIG. 4). Compliantmembers 152 may be spaced from internal tapered wall 114 in suspendedpivotal manner to provide a greater degree of deflection upon offsetentry of the surgical instrument. Compliant members 152 are arranged todefine a general frusto-conical shape extending radially inwardlyrelative to the seal axis “s” from proximal to distal, and may befurther arranged such that adjacent compliant members 152 are inoverlapping or partial overlapping relation with each other. Compliantmembers 152 are flexible to deflect, bend, etc. upon engagement with theinserted surgical object and are preferably fabricated from onelastomeric material. Any shape, including, but not limited to,rectangular, rounded, triangular, etc. are envisioned for complaintmembers 152.

It will be understood that various modifications and changes in form anddetail may be made to the embodiments of the present disclosure withoutdeparting from the spirit and scope of the invention. Therefore, theabove description should not be construed as limiting the invention butmerely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision other modifications within the scopeand spirit of the present invention as defined by the claims appendedhereto. Having thus described the invention with the details andparticularity required by the patent laws, what is claimed and desiredprotected is set forth in the appended claims.

1. (canceled)
 2. A surgical seal assembly, comprising: a seal housingdefining a longitudinal axis; a seal having an inner seal portiondefining a passage and being adapted to seal about a surgical instrumentdisposed within the passage; and a guide mounted adjacent an internaltapered wall of the seal housing and longitudinally fixed relative tothe seal, at least a portion of the guide being longitudinally alignedwith and disposed radially inward of the internal tapered wall of theseal housing.
 3. The surgical seal assembly according to claim 2,wherein the guide includes an inner guide portion proximal of the innerseal portion of the seal and spaced therefrom, and wherein the innerguide portion of the guide includes an elastomeric material.
 4. Thesurgical seal assembly according to claim 3, wherein the inner guideportion defines a channel adapted to direct the surgical instrumenttoward the inner seal portion of the seal upon entry of the surgicalinstrument within an opening of the seal housing, and wherein thechannel of the inner guide portion is tapered in configuration, having aproximal entry opening and a distal exit opening, the distal exitopening defining an internal dimension less than a correspondinginternal dimension of the proximal entry opening.
 5. The surgical sealassembly according to claim 4, wherein the channel defines afrusto-conical configuration.
 6. The surgical seal assembly according toclaim 2, wherein the guide includes a plurality of compliant members,each compliant member of the plurality of compliant members extendingradially inwardly relative to the longitudinal axis.
 7. The surgicalseal assembly according to claim 6, wherein each compliant member of theplurality of compliant members is mounted in a cantilevered relation tothe seal housing.
 8. The surgical seal assembly according to claim 7,wherein the plurality of compliant members is arranged such thatadjacent compliant members of the plurality of compliant members atleast partially overlap each other.
 9. The surgical seal assemblyaccording to claim 6, wherein each compliant member of the plurality ofcompliant members extends in a direction having radial and longitudinalcomponents of direction relative to the longitudinal axis.
 10. Thesurgical seal assembly according to claim 4, wherein the seal housingincludes an internal wall defining an internal dimension less than aninternal dimension of a proximal entry opening of the channel of theinner guide portion to restrict an internal dimension of a longitudinalopening of the seal housing.
 11. The surgical seal assembly according toclaim 2, wherein the seal housing defines a channel including a taperedsection, and wherein the guide is spaced from the tapered section alongthe longitudinal axis.
 12. The surgical seal assembly according to claim2, wherein the guide defines surfaces extending along axes intersectingthe longitudinal axis.
 13. The surgical seal assembly according to claim2, wherein the guide is spaced from the seal along the longitudinal axisin a manner preventing interference with functioning of the seal. 14.The surgical seal assembly according to claim 2, wherein the guide issuspended from the internal tapered wall of the seal housing.
 15. Thesurgical seal assembly according to claim 2, wherein the internaltapered wall of the seal housing is positioned and arranged to beprevented from contacting the surgical instrument during insertion ofthe surgical instrument.
 16. A surgical seal assembly, comprising: aseal housing having a longitudinal opening therethrough; a seal havingan inner seal portion adapted to seal about a surgical instrument; and aguide mounted to an internal tapered wall of the seal housing andlongitudinally fixed relative to the seal.
 17. The surgical sealassembly according to claim 16, wherein an inner guide portion of theguide is isolated from the inner seal portion of the seal to notinterfere with functioning of the seal.
 18. The surgical seal assemblyaccording to claim 16, wherein the guide includes a plurality ofcompliant members coaxially arranged about a longitudinal axis definedby the seal housing.
 19. The surgical seal assembly according to claim16, wherein the guide is disposed proximally of the seal.
 20. Thesurgical seal assembly according to claim 16, wherein the guide isspaced from the seal along a longitudinal axis defined by the sealhousing in a manner preventing interference with functioning of theseal.